Clinical Outcomes of Bioactive Glass S53P4 in Radical Mastoid Cavity Obliteration

N/AEnrolling By InvitationNCT07496112

Azienda Socio Sanitaria Territoriale Ovest Milanese, Ospedale di Legnano50 enrolled

Overview

Radical cavities resulting from open tympanoplasty performed for chronic cholesteatomatous otitis may lead to postoperative complications and negatively affect patients' quality of life. These cavities can remain unstable and may be associated with persistent otorrhea, limitations in the use of hearing aids, and the need to avoid water exposure, all of which may significantly impact daily activities. Although mastoid and paratympanic cavity obliteration techniques are increasingly used during primary surgery, many patients previously treated with open tympanoplasty continue to present with problematic postoperative cavities. Obliteration procedures have been proposed in revision surgery to improve cavity stability and reduce complications. Bioactive glass S53P4 has recently attracted interest as an obliterative material due to its long-term stability, biocompatibility, antibacterial properties, and ability to integrate with surrounding tissues. However, evidence regarding the medium-term clinical outcomes of this approach remains limited. The aim of this study is to evaluate the clinical effectiveness and safety of mastoid cavity obliteration using bioactive glass S53P4 in patients with radical cavities following open tympanoplasty. The study will assess surgical success, complication rates, and the impact of the procedure on patient quality of life.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Tympanoplasty

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * underwent a canal wall down tympanoplasty or a previous obliteration attempt more than a year ago * present with symptoms related to unstable cavity such as discharge, vertigo, impaired water activities or difficulty with hearing aids will be included * patients Over 18 years who signed informed consent Exclusion Criteria: * Active cholesteatoma * Earlier radiation of Head and Neck area * Pregnancy * Important systemic comorbidities

Outcomes

Primary Outcomes

Quality of Life Improvement After Mastoid Cavity Obliteration With S53P4

Change in quality of life assessed using the Chronic Otitis Media Questionnaire-12 (COMQ-12). The COMQ-12 is a validated questionnaire with total scores ranging from 0 to 60, where higher scores indicate worse quality of life and greater disease severity. The outcome is defined as the mean change in total COMQ-12 score from preoperative assessment to postoperative follow-up. Unit of measure: Points (COMQ-12 score).